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IRCT20210112050013N1 IRCT 2021-03-02 Bojnourd University of Medical Sciences The effect of probiotics on salivary pH and flow rate : The effect of probiotics on salivary pH and flow rate in healthy subjects, A double blinded, randomized, controlled trial 2021-03-16 anticipated 60 Complete https://irct.ir/trial/53717 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In order to randomize, the layering method will be used, in which people are first, divided into four layers based on age and gender, and randomization will be done in each layer. Also, to create a balance in the samples allocated in each of the layers, the block randomization method will be used (The blocks will be formed using a table of random numbers and assigning code 1 to even numbers and code 2 to odd numbers and moving left to right in each layer).In this way, the extracted codes will be placed in sealed envelopes and when each participant enters the study, according to the mentioned layer, the envelopes of that layer will be randomly assigned to him. And according to the assigned codes in an independent center, the decision to allocate the main drug and placebo will be made (intervention and control).At all stages of the study, neither the participants nor the outcome assessment officials are aware of the groups and only follow the study based on the assigned codes and record the consequences, Blinding description: Drugs and placebo in a separate center are marked with codes one and two assigned to the accident without informing the research team (participants, principal investigator and analyst). 4 Condition 1: Saliva flow rate. Condition 2: Saliva pH. Intervention 1: In the intervention group, lactogam probiotic lozenges containing Streptococcus salivarius K12 and Streptococcus salivarius M18, (CFU <109) with natural mint flavor and without sugar, produced by Zist Takhmir Company, were used as a medicin. People take one of these pills a day for 30 days. In this way, the person puts the pill in his mouth and allows the pill to dissolve completely in his mouth and then does not want to eat or drink for at least an hour. Intervention 2: In the comparison group, we use 30 placebo pills that have the same shape, color and composition as the previous pills but without probiotic content (placebo lozenges containing starch with natural mint flavor and no sugar).These pills are taken in the same way as the previous group. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Javid Rasekhi
Al-Zahra Student Dormitory، Block 1، Alley 6، Shahriyar St.، Al-Ghadir Complex
Bojnurd Iran (Islamic Republic of) 9415837413 +98 58 3228 9322 zohrehamiri23@yahoo.com Bojnourd University of Medical Sciences scientific Javid Rasekhi
Al-Zahra Student Dormitory، Block 1، Alley 6، Shahriyar St.، Al-Ghadir Complex
Bojnurd Iran (Islamic Republic of) 9415837413 +98 58 3228 9322 Zohrehamiri23@yahoo.com Bojnourd University of Medical Sciences Iran (Islamic Republic of) Healthy people aged 20 to 40 who fill out an informed consent form 20 years 40 years Both Presence of a marked systemic disease History of smoking and alcohol consumption Pregnancy and lactation status Patients with complete edentulousness There are specific symptoms of dry mouth, including fissure lip and palate, rampant caries, fungal infections, adhesions of the tongue and mucous membranes to the teeth, etc History of consumption of other products containing probiotics in the past month History of taking any medication, including antibiotics, antiseptics, Saliva reducing or increasing drugs in the past month Treatment - Drugs Placebo In the intervention group, lactogam probiotic lozenges containing Streptococcus salivarius K12 and Streptococcus salivarius M18, (CFU <109) with natural mint flavor and without sugar, produced by Zist Takhmir Company, were used as a medicin. People take one of these pills a day for 30 days. In this way, the person puts the pill in his mouth and allows the pill to dissolve completely in his mouth and then does not want to eat or drink for at least an hour. In the comparison group, we use 30 placebo pills that have the same shape, color and composition as the previous pills but without probiotic content (placebo lozenges containing starch with natural mint flavor and no sugar).These pills are taken in the same way as the previous group Number of digital scales. Timepoint: Measurement of salivary flow rate at the beginning of the study (before the intervention), one and two months after the start of probiotic use. Method of measurement: Digital scale device. Number digital pH meter. Timepoint: Measurement of saliva pH at the beginning of the study (before the intervention), one and two months after the start of probiotic use. Method of measurement: Digital pH meter. Bojnourd University of Medical Sciences Approved 2021-01-11 Ethics Committee of North Khorasan University of Medical Sciences Al-Zahra Student Dormitory، Block 1، Alley 6، Shahriyar St.، Al-Ghadir Complex bojnurd North Khorasan Iran (Islamic Republic of)